Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma (LIFT)
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ClinicalTrials.gov Identifier: NCT01275209 |
Recruitment Status :
Completed
First Posted : January 12, 2011
Last Update Posted : December 8, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Follicular Lymphoma | Drug: HCD122 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase Ib, Multicenter, Open-label Study of HCD122 Administered Intravenously in Combination With Bendamustine in Patients With CD40+ Follicular Lymphoma Who Are Refractory to Rituximab |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: HCD122 |
Drug: HCD122
Other Name: Lucatumumab |
- Incidence rate of dose-limiting toxicities and adverse events [ Time Frame: 2 years ]
- Response rate [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Confirmed diagnosis of follicular lymphoma, according to the Revised European American Lymphoma/World Health Organization [REAL/WHO] classification
- Documented CD40+ follicular lymphoma
- Measurable lesion
- Refractory to rituximab
- Prior treatment with at least 1 chemotherapeutic regimen
- 18 years or older
- WHO Performance Status grade 0, 1, or 2
- Life expectancy > 3 months
- Obtained written informed consent
Exclusion Criteria:
- Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma (i.e. DLBCL)
- History of another primary malignancy that is currently clinically significant or currently requires active intervention
- Prior allogeneic stem cell transplantation
- Prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration
- Impaired cardiac function or clinically significant cardiac disease
- History of acute or chronic pancreatitis, surgery of the pancreas, or any risk factors that may increase the risk of pancreatitis
- History of an active infection (viral, bacterial, or fungal) requiring systemic therapy within 28 days before study treatment.
- Known diagnosis of human immunodeficiency virus (HIV) infection
- Evidence of previous hepatitis viral infection such as hepatitis B or hepatitis C
- Ongoing corticosteroid use (>10 mg/day prednisone or equivalent)
- Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275209
United States, Massachusetts | |
Dana Farber Cancer Institute SC-5 | |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6) | |
Detroit, Michigan, United States, 48201 | |
United States, North Carolina | |
Duke University Medical Center Duke Hem & Onc | |
Durham, North Carolina, United States, 27710 | |
United States, Tennessee | |
Sarah Cannon Research Institute SC - 2 | |
Chattanooga, Tennessee, United States, 37404 | |
Australia, Victoria | |
Novartis Investigative Site | |
Prahran, Victoria, Australia, 3181 | |
Belgium | |
Novartis Investigative Site | |
Gent, Belgium, 9000 | |
Novartis Investigative Site | |
Leuven, Belgium, 3000 | |
Canada, Ontario | |
Novartis Investigative Site | |
Toronto, Ontario, Canada, M5G 2M9 | |
France | |
Novartis Investigative Site | |
Paris, France, 75475 | |
Italy | |
Novartis Investigative Site | |
Torino, TO, Italy, 10126 | |
Spain | |
Novartis Investigative Site | |
Barcelona, Cataluña, Spain, 08035 | |
Novartis Investigative Site | |
Madrid, Spain, 28046 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01275209 |
Other Study ID Numbers: |
CHCD122A2104 2010-022350-17 ( EudraCT Number ) |
First Posted: | January 12, 2011 Key Record Dates |
Last Update Posted: | December 8, 2020 |
Last Verified: | December 2012 |
HCD122 Lucatumumab CD40 |
Follicular Lymphoma Non-Hodgkin's Lymphoma Antibody |
Lymphoma Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |